A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epithelial Ovarian Cancer; Extraovarian Peritoneal Cancer; Fallopian Tube Carcinoma
Intervention: Ontak (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Tyler Curiel Official(s) and/or principal investigator(s): Tyler Curiel, MD, PhD, Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio
Summary
This study tests whether denileukin diftitox will deplete regulatory T cells, boost
tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or
who are ineligible for front line therapy.
Clinical Details
Official title: A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, of Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants Demonstrating Clinical Response
Secondary outcome: Toxicity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Able to provide informed consent
- Not on Immune modulating drugs
- Life expectancy less than 6 months
Exclusion Criteria:
- Unable to tolerate phlebotomy
- Germ cell or stromal cell cancers of the ovaries
- Active autoimmune disease
Locations and Contacts
CTRC at UTHSCSA, San Antonio, Texas 78229, United States
Additional Information
Starting date: February 2007
Last updated: January 7, 2013
|